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Quality Management System


Courses

42-01 - Control of Quality System Documents
Review all QMS controlled procedures, work instructions, & associated forms to control the QMS
Quality Manager Quality Manager
42-02 - Medical Device File
Review all QMS controlled procedures, work instructions, & associated forms to control a Medical Device File
Quality Manager Quality Manager
42-03 - Control of Records
Review all QMS controlled procedures, work instructions, & associated forms to Control Records
Quality Manager Quality Manager
42-04 - Control of Engineering Documents & Data
Review all QMS controlled procedures, work instructions, & associated forms to Control Engineering Documents/Data
Quality Manager Quality Manager
56-01 - Management Review
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Management Review
​Quality Management Representative ​Quality Management Representative
62-01 - Competence, Awareness, & Training
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Training
Human Resources Human Resources
63-01 - Infrastructure
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Infrastructure
VP of Operations VP of Operations
64-01 - Work Environment
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Work Environment
Production Manager Production Manager
71-01 - Product Realization (NPI)
Review all QMS controlled procedures, work instructions, & associated forms used for New Product Introduction (NPI)
Engineering Manager Engineering Manager
71-02 - Risk Management
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Risk Management
Engineering Manager Engineering Manager
71-03 - Process Development & Product Validation
Review all QMS procedures, work instructions, & associated forms used for Validation activities.
Engineering Manager Engineering Manager
72-01 - Customer Related Processes
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Project Management
Engineering Manager Engineering Manager
72-02 - Mold Design
Review all QMS controlled procedures, work instructions, & associated forms used for Mold Design activities
Director of Tooling Operations Director of Tooling Operations
74-01 - Purchasing
Review all QMS controlled procedures, work instructions, & associated forms used for Purchasing activities
Supply Chain Manager Supply Chain Manager
75-01 - Production Control (Unity)
Review all QMS controlled procedures, work instructions, & associated forms used for Production Molding activities
Production Manager Production Manager
75-02 - Production Control (Foley)
Review all QMS controlled procedures, work instructions, & associated forms used for Tooling activities
Director of Tooling Operations Director of Tooling Operations
76-01 - Control of Monitoring & Measuring Devices
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Calibration activities
Inspection Manager Inspection Manager
82-01 - Feedback
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Feedback
Quality Manager Quality Manager
82-02 - Internal Audits
Review all QMS controlled procedures, work instructions, & associated forms used for Internal Auditing activities
Quality Manager Quality Manager
82-03 - Inspection
Review all QMS controlled procedures, work instructions, & associated forms used for Inspection activities
Inspection Manager Inspection Manager
82-04 - Regulatory Authorities
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Regulatory Authorities
President President
83-01 - Non-Conforming Material (Unity)
Review all QMS controlled procedures, work instructions, & associated forms use to control Non-Conforming Material
Quality Manager Quality Manager
83-02 - Non-Conforming Material (Foley)
Review all QMS controlled procedures, work instructions, & associated forms use to control Non-Conforming Material
Director of Tooling Operations Director of Tooling Operations
84-01 - Analysis of Data
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Performance Analysis
Quality Manager Quality Manager
85-01 - Continual Improvement
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Continuous Improvement
Quality Manager Quality Manager
85-02 - Customer Advisory Notification
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Customer Notifications
VP of Operations VP of Operations
85-04 - Corrective Action
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Corrective Actions
Quality Manager Quality Manager
85-05 - Preventative Action
Review all QMS controlled procedures, work instructions, & associated forms pertaining to Preventative Action
Quality Manager Quality Manager